F. prausnitzii EXL01 live biotherapeutic trial in Crohn's disease
63 gut metagenome samples from 8 adult Crohn's disease patients in a first-in-human, open-label, single-arm trial of oral F. prausnitzii strain EXL01 following steroid-induced remission. machine-written summary
63 samples · 63 runs · Adult · 2026 · 5.82 Gbp / sample
Checked this project's papers and archive records yourself? Mark it human-verified.
what each source gave
| ✓ Sequence archive | 126 sample values (subject id, timepoint) |
| ○ Abstract / description | read; no usable statement |
| ✓ Full text | 189 sample values (collection date, health condition, health condition detail) · PMC13332046 |
| ○ Supplementary tables | files read; no table could be matched to the samples |
| – External resources | not covered by the external resources we ingest |
| – User contribution | nothing uploaded yet |
| – Human verified | not yet checked by a person · I checked this project — verify it |
intervention — arms not resolved
Defined bacterial consortium / live biotherapeutic product design single_arm_before_after · population crohns_disease · Oral F. prausnitzii strain EXL01, single-arm, open-label
“open-label, single-arm study of oral EXL01” — bioproject.description (study level; per-sample arms are in the intervention column below)
longitudinal — not resolved
8 of 8 people sampled more than once (63 samples; median 8, up to 9 per person). Schedule stated by the source: “biopsies and samples at IV2 (before treatment start) and W24 (end of EXL01 treatment), with 30-day post-treatment follow-up” (time origin: intervention_start); stated follow-up 30 d.
No Sandpiper profile for this project's samples yet.
| field | samples | coverage | R1 | R2 | R3 | R4 |
|---|---|---|---|---|---|---|
| age_category | 63 | 100% | ||||
| country | 0 | 0% | ||||
| health_condition | 63 | 100% | 63 | |||
| subject_id | 63 | 100% | 63 | |||
| collection_date | 63 | 100% | 63 | |||
| health_condition_detail | 63 | 100% | 63 | |||
| timepoint_label | 63 | 100% | 63 |
- Faecalibacterium prausnitzii EXL01 for the Maintenance of Steroid-induced Clinical Response or Remission in Patients with Crohn's Disease: a first in human trial. 2026 PMID 42049742 PMC13332046 own_data
Archive description
A marked decrease in Faecalibacterium prausnitzii is a hallmark of Crohn’s disease (CD)-associated dysbiosis and predicts disease relapse. Here, we present the development and first-in-human evaluation of F. prausnitzii strain EXL01 for CD treatment. The EXL01-strain demonstrates anti-inflammatory effects in four models of colitis in rodents. A first-in-human, open-label, single-arm study of oral EXL01 was conducted in eight adult participants with mild to moderate CD, following corticosteroids-induced clinical response or remission. The primary endpoint was safety, and secondary endpoints included clinical, endoscopic, histological, molecular, and microbiome assessments. EXL01 is well-tolerated with no treatment-related adverse events. Six participants completed the study two discontinued treatment due to disease flare. While gut microbiota composition remains largely stable, transcriptomic analyses reveal distinct changes in ileal gene expression following EXL01 treatment, notably modulation of immune-related genes and upregulation of energy metabolism pathways. Compared to participants who remained in remission, those who flared show higher baseline systemic inflammation markers and innate immunity gene expression. These findings demonstrate that oral administration of EXL01 is feasible and well tolerated and establishes proof-of-concept for F. prausnitzii as a first-in-class live biotherapeutic for CD. ClinicalTrials.gov registration: NCT05542355.
How this project entered the registry
Classified as human gut / stool / oral cavity shotgun DNA metagenome of adult by deterministic_prior with confidence 0.90. Assay shotgun_dna.
- host external_curation.infant_catalog · “infant triage reason_code age_adult_only”
- body site study.title · “Faecalibacterium prausnitzii EXL01 for”
- body site study.description · “marked decrease in Faecalibacterium prausnitzii is a”
- body site study.description · “single-arm study of oral EXL01 was conducted”
- life stage external_curation.infant_catalog · “infant triage reason_code age_adult_only”
- life stage study.description · “conducted in eight adult participants with mild”
Evidence examples (one per field × route)
| sample | field | value | route | conf. | source | quote |
|---|---|---|---|---|---|---|
| SAMEA122064577 | collection_date | 2023-03/2024-10 | R3 | 0.60 | paper.fulltext.results | From March 2023 through October 2024, 13 participants |
| SAMEA122064577 | health_condition | crohns_disease | R3 | 0.70 | paper.fulltext.abstract | eight adult participants with mild to moderate CD |
| SAMEA122064577 | health_condition_detail | mild to moderate Crohn's disease (CD) | R3 | 0.70 | paper.fulltext.abstract | eight adult participants with mild to moderate CD |
| SAMEA122064577 | subject_id | P1 | R1 | 0.85 | sample.attr.host_subject_id | P1 |
| SAMEA122064577 | timepoint_label | Shotgun, P1, feces, Safety_Follow-up | R1 | 0.85 | biosample.attribute:description | Shotgun, P1, feces, Safety_Follow-up |
Sequencing
63 runs over 63 samples · mean 5.65 Gbp per run (median 5.82 Gbp, total 356.16 Gbp; 63 runs with a base count) · layout PAIRED 63 · platform ILLUMINA 63 · models Illumina NovaSeq X (63) · 0% of runs with a Sandpiper profile · first public 2026-04-03
Authors (14)
Guarino-Vignon P first · Louis E · Pham HP · Orianne G · Tkacz E · Brot L · Mazzetti E · Sedda D · Ruffié P · Rolhion N · D'Haens G · Hadida B · Langella P · Sokol H last
Downloads
PRJEB110888.csv.gz (2.5 KB) · parquet (71.7 KB) — all 63 samples, every field with route and confidence · PRJEB110888_determinations.csv.gz (2.7 KB) — 315 evidence rows